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A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

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Vertex Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Cystic Fibrosis

Treatments

Drug: VX-445/TEZ/IVA
Drug: IVA
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03525444
VX17-445-102
2018-000183-28 (EudraCT Number)

Details and patient eligibility

About

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

Enrollment

405 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Heterozygous for the F508del mutation (F/MF)
  • Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for age, sex, and height

Key Exclusion Criteria:

  • Clinically significant cirrhosis with or without portal hypertension
  • Lung infection with organisms associated with a more rapid decline in pulmonary status
  • Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

405 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Participants who received placebo matched to VX-445/TEZ/IVA for 24 weeks in the TC treatment period.
Treatment:
Drug: Placebo
VX-445/TEZ/IVA TC
Experimental group
Description:
Participants who received VX-445 200 mg/TEZ 100 mg/IVA150 mg as fixed-dose combination (FDC) tablets in the morning and IVA 150 mg as mono tablet in the evening for 24 weeks in the TC treatment period.
Treatment:
Drug: IVA
Drug: VX-445/TEZ/IVA

Trial documents
2

Trial contacts and locations

115

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Data sourced from clinicaltrials.gov

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